Assiut Univeristy
Asyut, 12346, Egypt
Location status: Recruiting
Location contact
Basel K Mohamed
CONTACT
Recruiting
NCT Number: NCT06694532
EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders
The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.
3-The presence of absence of clicking and cracking in jaw .
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Pain or tenderness of the jaw
- Pain in one or both of the temporomandibular joints
- Aching pain in and around your ear
- Difficulty chewing or pain while chewing
- Aching facial pain
- Locking of the joint,
Exclusion criteria
- Muscular TMJ disorders
- Bleeding tendency
Treatment and study plan
Hyaluronic acid
DrugComparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device
Other names: Arthrocentesis
Syringes
DeviceWhilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products .
Other names: Arthrocentesis
Primary outcomes
-
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
Time frame: 36 months
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
, 1- significantly improving the pain on scale 1-10 , and
Secondary outcomes
-
comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis
Time frame: 36 months
The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.
2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Basel khaled mohamed
Other
Registry information
Official study title
Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 19, 2024
- Registry last updated
- Nov 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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